Hematopoietic Cell TransplantNCT03345433
Interactive Group Drumming (IGD) in Hospital Experience of Patients Undergoing Hematopoietic Stem Cell Transplant - A Pilot Study
A study testing interactive group drumming sessions in people with Hematopoietic Cell Transplant, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Cell Transplant
- What is being tested?
- interactive group drumming sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 4 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who are at least 18 years old and are scheduled for HCT
- Individuals must be able to understand and willing to sign a written informed consent form
Who cannot join
- People who are too ill to participate, i.e., while they are in contact isolation or have low platelets (less than 20,000/mcl) will not participate until their condition has improved.
- Patients receiving outpatient HCT except patients with multiple myeloma. Patients with multiple myeloma may participate in the study even though they tend to spend nights away from the hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Does Interactive Group Drumming (IGD) Improve the Hospital Experience of Patients Undergoing Hematopoietic Stem Cell Transplant? - A Pilot Study
The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.
Read the detailed description
The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.
- Conditions
- Hematopoietic Cell Transplant
- Being tested
- interactive group drumming sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive group drumming sessionsBehavioural
interactive group drumming sessions
| Study group | Role | What they receive |
|---|---|---|
| interactive group drumming sessions | Experimental | Participants will be involved in four interactive group drumming sessions (10-30 minutes each) and complete surveys and questionnaires about music and quality of life. Receives: Behavioral: interactive group drumming sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participation
Defined as the number of subjects willing to participate in the interactive group drumming (IGD) divided by the number approached and asked to participate. These rates will be reported, along with the corresponding 95% confidence interval.
Measured: Up to 1 week after hematopoietic cell transplant (HCT)
Rate of completion
Defined as the ratio of (the number of individuals who successfully complete the study [4 sessions of IGD (about 20 minutes [min.] each)], with two pre-and post- surveys [8 minutes total, and two questionnaires (10 minutes total) about 160 minutes total time]) relative to the number of individuals who consent to the study (the number from the numerator of the first ratio [participation]). These rates will be reported, along with the corresponding 95% confidence interval.
Measured: Up to 1 week after HCT
Secondary outcomes (6)
Gather patient-reported data to suggest how participants respond to interactive group drumming (IGD)
Will be assessed by STADID Short Form Y-1. The after-IGD session measure will include a patient satisfaction item as well. The mean and standard deviation for each of these measures will be calculated.
Measured: Baseline up to 4 weeks after completion of IGD
Determine optimum length of session
Will be assessed by comparing actual length of session reported on facilitator post-session observation forms with participant satisfaction as reported in post-session. The mean and standard deviation for each of these measures will be calculated.
Measured: Up to 4 weeks after completion of IGD
Gather patient-reported information to study whether the effect of interactive group drumming (IGD) on targeted variables is more pronounced in successive sessions
Targeted variables defined as anxiety, energy mood, distress, relaxation, pain, and patient satisfaction. Will compare for each participant. The mean and standard deviation for each of these measures will be calculated.
Measured: Baseline up to 4 weeks after completion of IGD
Effect of support care provider (SCP) presence for each participant and among participants
Will use a non-parametric test to compare difference in item scores with and without SCP presence.
Measured: Up to 4 weeks after completion of IGD
Change in physiological response to interactive group drumming (IGD)
Will be calculated at three time points during the session; repeated measures analysis of variance will be used to detect changes over the 3 readings.
Measured: Baseline up to 1 week after HCT
Gather patient-reported information to suggest the optimal number of interactive group drumming (IGD) sessions
Will be assessed by STADID Short Form Y-1. The after-IGD session measure will include a patient satisfaction item as well. The mean and standard deviation for each of these measures will be calculated
Measured: Baseline up to 4 weeks after completion of IGD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Nov 2017
- Primary completion25 Sep 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Cell TransplantStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interactive group drumming sessions
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard McQuellon, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345433
- Sponsor's protocol ID
- IRB00046180
- Other IDs
- CCCWFU 04417
- Status last verified
- Dec 2019
- First submitted
- 20 Oct 2017
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Interactive Group Drumming (IGD) Improve the Hospital Experience of Patients Undergoing Hematopoietic Stem Cell Transplant? - A Pilot Study
- ClinicalTrials.gov ID
- NCT03345433
- Acronym / sponsor ID
- IRB00046180
- Conditions
- Hematopoietic Cell Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.
Detailed description
The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interactive group drumming sessions
| Arm | Type | Receives |
|---|---|---|
| interactive group drumming sessions | Experimental | Behavioral: interactive group drumming sessionsParticipants will be involved in four interactive group drumming sessions (10-30 minutes each) and complete surveys and questionnaires about music and quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People who are at least 18 years old and are scheduled for HCT
- Individuals must be able to understand and willing to sign a written informed consent form
Key exclusion criteria (2 listed)
- People who are too ill to participate, i.e., while they are in contact isolation or have low platelets (less than 20,000/mcl) will not participate until their condition has improved.
- Patients receiving outpatient HCT except patients with multiple myeloma. Patients with multiple myeloma may participate in the study even though they tend to spend nights away from the hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interactive group drumming sessionsinteractive group drumming sessions | Behavioural | interactive group drumming sessions |
Primary outcome
Rate of participation
Time frame: Up to 1 week after hematopoietic cell transplant (HCT)
Defined as the number of subjects willing to participate in the interactive group drumming (IGD) divided by the number approached and asked to participate. These rates will be reported, along with the corresponding 95% confidence interval.
Rate of completion
Time frame: Up to 1 week after HCT
Defined as the ratio of (the number of individuals who successfully complete the study [4 sessions of IGD (about 20 minutes [min.] each)], with two pre-and post- surveys [8 minutes total, and two questionnaires (10 minutes total) about 160 minutes total time]) relative to the number of individuals who consent to the study (the number from the numerator of the first ratio [participation]). These rates will be reported, along with the corresponding 95% confidence interval.
6 secondary outcomes
Gather patient-reported data to suggest how participants respond to interactive group drumming (IGD)
Time frame: Baseline up to 4 weeks after completion of IGD
Determine optimum length of session
Time frame: Up to 4 weeks after completion of IGD
Gather patient-reported information to study whether the effect of interactive group drumming (IGD) on targeted variables is more pronounced in successive sessions
Time frame: Baseline up to 4 weeks after completion of IGD
Effect of support care provider (SCP) presence for each participant and among participants
Time frame: Up to 4 weeks after completion of IGD
Change in physiological response to interactive group drumming (IGD)
Time frame: Baseline up to 1 week after HCT
Gather patient-reported information to suggest the optimal number of interactive group drumming (IGD) sessions
Time frame: Baseline up to 4 weeks after completion of IGD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
Related trials for Hematopoietic Cell Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard McQuellon, PhD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive group drumming sessions in people with Hematopoietic Cell Transplant, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participation (time frame: Up to 1 week after hematopoietic cell transplant (HCT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.